The face of research could be transformed under two policies proposed last week by the National Institutes of Health in conjunction with the federal Department of Health and Human Services.
To increase the amount of public research information, the proposed changes would require scientists to post results of trials of unapproved, unlicensed and uncleared products within a year of trial completion, the NIH said.
By taking these steps, NIH officials aim to avoid the duplication of unsuccessful or unsafe experimentation due to the lack of proper documentation. They also hope to encourage patient-researcher trust by ensuring that study participation won’t go to waste, the proposal said.
Researchers currently submit trial results to the government website
ClinicalTrials.gov. But only about 15,000 summary results have been published there, compared with existing registration information for 178,000 clinical trials.
University of Minnesota bioethics professor and clinical researcher Jim Neaton said the gap between publicly available results and outcomes of all trials needs to be addressed.
“This would make it possible to at least identify not only [that] those studies were planned and done but also the results,” he said.
Proposed changes include requiring summary reporting of unapproved products. The proposal also outlines procedures for requesting a deadline extension for reporting results, a rule that would give companies exploring trademarks and patents extra time to do so.
Franklin Sayre, liaison librarian to the College of Pharmacy, said he supports the proposed changes, adding that clinical trial researchers have a duty to report their findings — good or bad.
“Access can have very real benefits,” he said.
Positive trial results are more often reported than negative ones, Sayre said, which may not reflect reality.
While the proposed rules wouldn’t affect researchers and patients during a study’s trial period, Neaton said they would give patients a
valuable resource for exploring past research on their condition and the
opportunity to choose ideal treatment going forward.
“We have a responsibility when we put people into studies to report the results of them, and the best thing always is to report the results in a peer-reviewed journal,” he said.
Negative results, however, often go unpublished because researchers don’t find them “interesting” enough for the spotlight or can’t find places to publish them, Neaton and Sayre said.
Beyond the new proposed rules, Sayre said he could foresee a few other changes that would further increase the transparency of clinical trial results, including publishing the full clinical trial protocol and making comprehensive patient data available to researchers.
Still, Sayre and Neaton lauded the proposals’ implications for the NIH and the world of research.
“This is a step in the right direction,” Neaton said.
A public comment period is currently open to voice opinions on the proposals.